With its liquid biopsy test FDA approved and monitoring and screening offerings poised for launch, the firm is turning its attention to tumor tissue testing.
An Invitae-led retrospective study found almost a third of cancer patients who underwent germline genetic testing after tumor sequencing had pathogenic variants.
The LUNGevity Foundation and 41 stakeholders aim to reduce cancer patients' confusion about in vitro diagnostic testing by implementing two consistent umbrella terms.
Paired tumor/germline analysis is not routinely done in cancer care, but some labs are starting to report incidental germline findings alongside patient's tumor profiles.
Recent studies question the clinical utility of tumor mutational burden as a biomarker for immuno-oncology response, and the FDA clearance includes no therapeutic indications.
The approval of its Omics Core assay for tumor-normal mutational profiling opens the door for payor reimbursement, which is key to reaching profitability, NantHealth said.
